Mechanically registered videoscopic myringotomy/tympanostomy tube placement system

ABSTRACT

Devices, systems, methods, and kits for treating the tissue structures of the ear make use of a guide structure that can mechanically register a treatment probe with a target region of a target tissue, the guide structure being fittingly received in an auditory canal and often comprising a conformable body such as a compressible foam, or the like. The guide structure may include an articulating mechanism for selectively orienting the treatment probe toward the target region of, for example, a tympanic membrane. The guide structure may also support a videoscopic image capture device, illumination transmitting optical fibers, an aiming beam transmitter, and the like. Such structures facilitate myringotomy, tympanostomy tube placement, and the like, under local anesthesia in a doctor&#39;s office.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation of U.S. patent applicationSer. No. 14/660,972, filed Mar. 18, 2015, which is a continuation ofU.S. patent application Ser. No. 12/754,304, filed Apr. 5, 2010 (nowissued as U.S. Pat. No. 8,998,927), which is a continuation of U.S.patent application Ser. No. 10/841,420, filed May 6, 2004 (now issued asU.S. Pat. No. 7,704,259), which is a divisional application of U.S.patent application Ser. No. 09/843,541 filed Apr. 26, 2001 (now issuedas U.S. Pat. No. 6,770,080), the disclosures of each of which areincorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention is generally related to medical devices andapparatus. In particular, the invention provides systems, methods,devices, and kits for treating a patient's ear. In one embodiment, theinvention provides a system and method for myringotomy with or withouttympanostomy tube placement.

Otitis media is among the most common diagnosis made by pediatricians. Amajority of children may have at least one episode of otitis media(“earache”) prior to their third birthday. Otitis media is often causedby an inability of the eustachian tube to drain fluid from the middleear. Otitis media is often treated with antibiotics.

A significant number of children exhibit recurrent episodes of otitismedia and/or otitis media with effusion. Treatment of these more severecases often involves the placement of a tympanostomy tube through thetympanic membrane so as to provide adequate drainage of the middle earand reduce the likelihood of future infections. Tympanostomy tubesprovide fluid communication between the middle and outer ear, andtypically fall out spontaneously within about a year of placement.Tympanostomy tube placement is among the most common surgical proceduresperformed in the pediatric population. It has been estimated that morethan a million tympanostomy tubes may be placed each year, with typicalpatients being between about 18 months and 3 years of age at the time ofthe procedure.

Tympanostomy tube placement is typically performed in an out-patientsurgery setting under general anesthesia. The external auditory canaland tympanic membrane are examined under microscopic visualizationthrough a hand-held conical shaped speculum. An incision or myringotomyis made in the tympanic membrane, typically using an elongate, smallprofile scalpel which the physician extends through the conicalspeculum. Fluid may be aspirated through the myringotomy, and atympanostomy tube is placed so as to extend through the tympanicmembrane.

A wide variety of tympanostomy tubes are commercially available, and astill wider variety of others tubes have been proposed. A number ofsystems have been proposed to both perform the myringotomy and deploythe tympanostomy tube with a single treatment assembly. In recent years,more complex and expensive systems have been proposed for diagnosis ortreatment of the tissues of the ear, including systems using laserenergy for forming a myringotomy, video systems for imaging of the earcanal, and the like. These various alternatives have, not surprisingly,been met with varying degrees of acceptance.

A standard tympanostomy tube placement procedure is both effective andquite safe. Nonetheless, further improvements would be desirable. Inparticular, there are both risks and costs associated with out-patientsurgical procedures performed under general anesthesia. For example, asignificant portion of the risk and cost of tympanostomy tube placementis associated with the administration of general anesthesia, i.e., theneed for an operating room, the presence of an anesthesiologist, andrelated recovery room time.

In light of the above, it would be desirable to provide improveddevices, systems, methods, and kits for treatment of the tissuestructures within the auditory canal. It would generally be beneficialif these improvements facilitated myringotomy with or withouttympanostomy tube placement without having to resort to generalanesthesia, thereby allowing these common procedures to be performed ina doctor's office (rather than in an outpatient surgical facility). Itwould be further beneficial to maintain or enhance the physician'scontrol over the procedure by, for example, allowing verification ofintended and actual tympanostomy tube placement location, enhancedviewing and control, and improved safety. It would further be desirableif these improvements could be provided while decreasing the overallprocedure time, and ideally, at a reduced overall procedure cost.

SUMMARY OF THE INVENTION

The present invention provides improved devices, systems, methods, andkits for treating the tissue structures of the ear. The invention oftenmakes use of a guide structure that can mechanically register atreatment probe with a target region of the tympanic membrane oreardrum. Mechanical registration may be provided by a structure which isfittingly received in an external auditory canal of the ear. The guidestructure will often include a conformable body (typically comprising acompressible foam, or the like) so as to allow the guide structure toaccommodate a range of differing auditory canal anatomy. The guidestructure may further include an articulating mechanism for selectivelyorienting the treatment probe toward the target region of the tympanicmembrane. The articulating mechanism will often selectively orient aprobe lumen, with the treatment probe having a shaft fittingly slidingin the probe lumen so that engagement between a positioning surface ofthe guide structure and a tissue surface of the patient's ear maintainsregistration of the treatment probe. The guide structure may alsosupport a videoscopic image capture device, illumination transmittingoptical fibers, an aiming beam transmitter, and the like.Advantageously, such structures facilitate performing treatmentprocedures such as myringotomy, tympanostomy tube placement, and thelike, under local (rather than general) anesthesia, often in a doctor'soffice (rather than an out-patient surgical facility).

In a first aspect, the invention provides a method for treating an earof a patient. The ear has a tympanic membrane. The method comprisemechanically registering a guide structure with a target region of thetympanic membrane. The target region is treated by actuating a treatmentprobe while the treatment probe is oriented by the registered guidestructure.

Orientational alignment between the guide structure and the tympanicmembrane may be maintained by engagement between a surface of the guidestructure and an external auditory canal. This engagement may besufficient to maintain orientation of the treatment probe without manualsupport of the guide structure or treatment probe. The use of aconformable body of the guide structure can facilitate the orientationmaintaining engagement. The conformable body may comprise a compressiblefoam, a solid elastomer, a balloon, or the like, and may optionallyexpand radially within the auditory canal. An agent (such as a localanesthesia agent, an antiseptic agent, an antibiotic agent, or the like)may be dispensed from the guide structure, the agent optionally beingdispensed from the compressible foam. In alternative embodiments, one ormore such agents may be dispensed before insertion of the guidestructure and/or after its removal. In some embodiments, registration ofthe probe and target region may be provided at least in part byengagement (preferable in the form of gentle pressure) between the guidestructure and the skull (often the side of the skull) of the patient.

The guide structure may be registered by articulating a treatment lumenof the guide structure relative to a positioning surface of the guidestructure. For example, the guide structure may comprise a shafteccentrically carrying the treatment lumen. The shaft may rotate withinthe auditory canal about an axis with the treatment probe precessingabout the axis so as to orient the probe toward the target region. Thepositioning surface of the guide structure may be disposed over theshaft with a bearing therebetween to facilitate rotation without injuryto the tissue surface engaged by the positioning surface. The shaft mayflex during rotation so as to accommodate a bend of the auditory canal.The probe and/or other components of the treatment system within theguide structure may likewise flex during rotation.

Registration of the guide structure may be videoscopically directed, theguide structure optionally supporting a video image capture device. Thetympanic membrane may be illuminated by the guide structure, typicallyusing an illumination source and/or optics (such as a fiber opticbundle, glass rod, or other optical waveguide). The registration of theprobe with the target region may optionally be verified by displaying amarker indicating which portion of the tympanic membrane is aligned withthe probe. For example, an aiming beam may be transmitted onto thetympanic membrane from the guide structure to generate the marker orpointer. The aiming beam may comprise, for example, laser light energyhaving a frequency within the visible range. In some embodiments, areticule or image template may be superimposed on the image displayed tothe system operator to aid registration.

A system operator disposed in front of the patient may view an image ofthe tympanic membrane while a head of the patient is upright. The systemoperator may manipulate a handle coupled to the shaft of the guidestructure to register the guide structure and actuate the treatmentprobe. In the exemplary embodiment, the guide structure handle is alarge profile body, similar in appearance to an earmuff when in use. Thesystem of the present invention is particularly well-suited fortympanostomy tube placement without general anesthesia.

The treatment probe will typically pierce the tympanic membrane. Atympanostomy tube may be advanced through the pierced membrane, oftenwhile supporting the tympanostomy tube with the guide structure. Thetreatment probe may carry the tympanostomy tube.

Alternatively, separate probes may be used to pierce the membrane anddeploy the tympanostomy tube. In still further alternatives, themembrane may be pierced using laser energy or the like. Fluid may bedrained from distally of the pierced membrane by the treatment probe bya separate aspiration structure supported by the guide structure, or thelike. Fluid drainage may be effected by an aspiration lumen, by anabsorbent structure such as a blotting or wicking element, or the like.

In another aspect, the invention provides a system for treating an earof a patient. The ear has a tympanic membrane and a tissue surface. Thesystem comprises a guide structure having a proximal orientation and adistal orientation. The guide structure has a positioning surface. Atympanic membrane treatment probe is oriented by the guide structure.The guide structure maintains registration of the treatment probe with atarget region of the tympanic membrane when the positioning surfaceengages the tissue surface of the ear.

The tissue surface typically comprises an auditory canal. The guidestructure will often include a conformable body insertable into theauditory canal. A shaft may be rotatably disposed within the conformablebody so as to rotate about an axis. The treatment probe can be orientedeccentrically relative to the axis so that rotation of the shaftselectively registers the treatment probe with the target region. Theshaft may be laterally flexible to conform with a bend of the auditorycanal during rotation of the shaft. Similarly, the treatment probe mayalso be flexible.

The conformable body may comprise a compressible material such as afoam. In some embodiments, an agent such as a local anesthetic agent, anantiseptic and/or antibacterial agent, an antibiotic agent, and/or thelike may be disposed on or in the foam, or the agent may otherwise bedispensed from the guide structure. The guide structure may furtherinclude one or more aspiration and/or irrigation lumens, or such lumensmay alternatively be incorporated into the treatment probe. Suchaspiration and/or irrigation may be used to clear Cerumen (earwax) forimaging of the tympanic membrane, fluid accumulating distally of thetympanic membrane, and the like.

An image capture device may be supported by the guide structure forimaging the tympanic membrane. The image capture device may coupled to amonitor, the image capture device typically comprising a Charge-CoupledDevice (CCD) and associated imaging optics (such as a coherent fiberoptic bundle, one or more rod or standard lenses, and the like). Atleast a portion ofthe image capture device may be removably couplable tothe guide structure, which may allow the use of disposable guidestructures at a reasonable cost. An illumination source may also becarried on the guide structures for illuminating the tympanic membraneduring imaging. The exemplary illumination source may compriseillumination optical fibers.

The system will preferably include aiming means for identifying anorientation of the treatment probe relative to the tympanic membrane. Inmany embodiments, a light beam (such as from a laser or light-emittingdiode) may be directed onto the tympanic membrane at a location alignedwith the treatment probe. Alternative embodiments may make use of areticule superimposed on the image of the tympanic membrane as shown ina monitor to the system operator, a template superimposed on the imageto indicate the target region, or the like. Such aiming structures canverify registration of the treatment probe with the target regionbefore, during, and/or after piercing the tympanic membrane, tubedeployment, and the like.

The treatment probe will often have a distal tip for piercing thetympanic membrane. Optionally, the distal tip may comprise a cuttingedge or blade. A tympanostomy tube may be releasably carried on a shaftof the probe proximally of the tip. An exemplary tympanostomy tubecomprises a proximal flange and a distal flange with a tubular bodytherebetween, the tubular body having an elongate opening with a firstcross-sectional dimension and a second cross-sectional dimension greaterthan the first. The tip of the probe shaft may have a distal edgeoriented along the height when the tympanostomy tube is carried on theshaft. The distal surface of the distal flange of the tympanostomy tubemay angle proximally and radially outwardly to facilitate advancing thedistal flange through the myringotomy.

A limit surface of the treatment probe may engage a limit surface of theguide structure or the tympanic membrane so as to inhibit axial movementof the shaft after the probe pierces the tympanic membrane. This canhelp avoid inadvertent injury to the middle and/or inner ear structuresor undesired positioning of the tube distally of the tympanic membranewithin the middle ear. In the exemplary embodiment, engagement of thelimit surfaces inhibits movement when the distal end of the probeadvances from the guide structure by a distance in a range from about1.0 mm to about 40 mm.

The treatment probe may comprise a probe shaft disposed in a lumen ofthe guide structure. The probe shaft may be coupled to an actuator whichis accessible when the positioned surface engages the tissue surface.The probe shaft may advance axially with the lumen in response tomovement of the actuator. The lumen may be selectively repositionablerelative to the positioning surface for selective registration of thetreatment probe with the target region. For example, the lumen may besupported by a shaft which rotates relative to the positioning surface,with the lumen being eccentrically oriented and/or eccentricallydisposed relative to the axis of rotation of the shaft.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 schematically illustrates a tympanic membrane treating system.

FIG. 2 is a cross-sectional view of a guide structure andmyringotomy/tympanostomy probe for use in the system of FIG. 1.

FIGS. 2A and 2B schematically illustrate fluid delivery and/or removalsystems of the probe and guide structure, respectively.

FIG. 3 is an axial view of the distal end portion of the guide structureand treatment probe of FIG. 2.

FIG. 4 is a cross-sectional view of the guide structure.

FIGS. 5A-5F are front, side, and end views of a distal portion of thetreatment probe, showing an exemplary tympanostomy tube carried thereon.

FIG. 6 is a perspective view of an exemplary tympanostomy tube.

FIG. 7 schematically illustrates the tympanostomy tube of FIG. 6deployed through the tympanic membrane.

FIGS. 8A and 8B illustrate an alternative tympanostomy tube andtreatment probe for use in the system of FIG. 1.

FIGS. 9A-9G schematically illustrate an alternative treatment probe foruse in the system of FIG. 1.

FIG. 10 illustrates a tympanostomy tube treatment procedure according tothe principles of the present invention.

FIG. 11 illustrates a videoscopic image and its use for directing thetympanostomy tube placement procedure of FIG. 10.

FIG. 11A illustrates a display with a superimposed template forassisting registration.

FIG. 12 schematically illustrates a simplified model of an auditorycanal.

FIGS. 13A-13E schematically illustrate a method for using the guidestructure and treatment probe of FIG. 1 to deploy a tympanostomy tube ina target region of a tympanic membrane.

DETAILED DESCRIPTION OF THE INVENTION

The present invention generally provides improved devices, systems,methods, and kits for treatment of tissue structures of the ear.Myringotomy, tympanostomy tube placement, and other procedures may beperformed using a guide structure to register one or more treatmentprobes relative to the target tissue structure. The guide structure willoften be articulatable, allowing selective registration of the treatmentprobe with a target region of, for example, the tympanic membrane oreardrum. The guide structure may be supported by, for example, aconformable body, such as a compressible foam insertable into theexternal auditory canal.

Engagement between the conformable body and the auditory canal canmaintain a position of the guide structure so that the guide structure,in turn, maintains an orientation of the treatment probe. Such alightweight guide structure may be mountable to the patient, allowingstabilized videoscopic imaging from an image capture device supported bythe guide structure.

Illumination transmitting optical fibers, an aiming beam transmitter,aspiration/irrigation lumens, and other structures may be supported by asingle guide structure. Advantageously, such a stabilized systemfacilitates performing treatment procedures such as myringotomy with orwithout tympanostomy tube placement, and the like, under local (ratherthan general) anesthesia, often in a doctor's office (rather than anoperating room).

The structures and methods of the present invention will be particularlyuseful for accessing and treating the tissue structures of the ear.Using an image capture device which is supported by a guide structureaffixable relative to an adjacent tissue surface of the ear, the imagesof these small tissue structures will remain steady despite movements ofthe patient's head. A magnified scale of the image may greatly easeviewing of the target tissues, and as the treatment probe can also besupported by the guide structure, procedures may be directed withreference to an enlarged, stabilized image shown in a monitor, with muchgreater precision than a manual procedure performed under direct opticalimaging. Hence, while the invention may find its most immediateapplication in formation of myringotomies with or without tympanostomytube placement, and the like, the invention may find furtherapplications in a number of applications of the outer, middle, and orinner ear, including cerumen removal, tympanocentesis, foreign bodyremoval, ear implants, and the like.

Referring now to FIG. 1, a tympanostomy tube placement system 10comprises a probe assembly 12 coupled to a video monitor 14 by an imagetransmission cable 16. An illumination light source 18 (shownschematically) transmits illumination light to probe assembly 12 for usein imaging, and an aiming light source 20 (also shown schematically)transmits a pointer light beam to the probe assembly for registering theprobe assembly with a target tissue. An optical image of the auditorycanal and tympanic membrane may be transmitted from probe assembly 12 toa camera 19 (shown schematically), which transforms the optical imageinto image data in a form convenient for transmission, recording and/ormanipulation (the camera typically comprising a charge-coupled device or“CCD”). This image data is transmitted by camera 19 to monitor 14, againvia cable 16. Monitor 14 will often comprise a standard video display,optionally being part of a display rack system modified for use insystem 10. The rack may incorporate the illumination and/or aiming lightsources 18, 20, camera 19, an image storage unit 15 (such as avideo-cassette recorder, CD or DVD recorder, or the like), a printer,and/or the like. Suitable video rack systems may be commerciallyavailable from STRYKER, located at Santa Clara, Calif.

Illumination source 18 will generally comprise an incandescent lamp,fluorescent or arc lamp, light emitting diode, or the like, and willoften be optically coupled to illuminating optical fibers of cable 16 soas to transmit white imaging light to probe assembly 12. In otherembodiments, alternative illumination frequencies and/or sources mightbe used, ambient light may be sufficient, or non-optical imaging mightbe applied. Aiming light source 20 may comprise a laser or lightemitting diode (or the like) transmitting a light beam with a frequencyin the visible spectrum (such as a green light beam, a red light beam,or the like). The aiming light beam will often be transmitted to probeassembly 12 via dedicated optical fibers of cable 16 for directing of anaiming or pointer beam onto the target tissues so as to generate anaiming marker. Image transmission cable 16 may further comprise acoherent fiber optic bundle (particularly for transmission of an imagefrom probe assembly 12 to camera 19), a coaxial electrical cable(particularly for transmission of image date from camera 19 to monitor14), one or more data transmission optical fibers, and/or the like, andgenerally transmits an image from probe assembly 12 to monitor 14 foruse in videoscopically directing a tympanostomy tube placementprocedure. Cable 16 may also have an aspiration and/or irrigation lumen,or one or more separate fluid tubes may optionally be coupled to probeassembly 12 for clearing of cerumen to enhance image quality, aspiratingfluids from the middle ear, or the like. Optionally, agents such asantibiotic, antibacterial, cerumenolytics, and/or local anestheticagents may be included (alone or in combination) with irrigation flow.Suitable local anesthetic agents include lidocaine, bupivacaine,benzocaine, prilocaine, lidocaine/prilocaine in a eutectic mixture,tetracaine, and the like. Suitable antibiotics include neomycin,polymixin B, ciprofloxacin, ofloxin, and the like. Suitablecerumenolytics may include Triethanolamine polypeptide oleatecondensate,hydrogen peroxide, and the like. Suitable antibacterial agents includeaqueous aluminum acetate, acetic acid, and the like.

Referring now to FIGS. 1-4, treatment probe assembly 12 generallyincludes a guide structure 22 and a treatment probe 24. Guide structure22 generally includes a shaft 26 having a proximal end 28 and a distalend 30, at least a portion of the shaft adjacent distal end 30 beingsafely insertable into an external auditory canal of the patient. Apositioning surface 32 disposed about the shaft 26 is defined by aconformable body 34.

Conformable body 34 may comprise a compressible foam, and willpreferably comprise a urethane foam. Alternatively, conformable body 34may comprise a material such as gum rubber compounds, urethanes,fluorocarbon elastomer, butyl rubber, EPDM (Ethylene-Propylene Rubber),latex rubber, neoprene (polychloroprene), nitrile rubber(acrylonitrile), polybutadiene, silicone rubber, SBR (Stryrene-ButadieneRubber), HNBR (Hydrogenated Nitrile Rubber), fluoroelastomer,fluorosilicone. Conformable body 34 can safely engage the surroundingauditory canal with sufficient force and/or friction to inhibit movementof the guide structure during imaging and treatment. Conformable body 34may expand resiliently within the external auditory canal, or theconformable body may comprise a selectably expandable body such as aballoon. In other embodiments, conformable body 34 may comprise a softsolid elastomer, a plastically deformable polymer, or the like.

An inner shaft 36 is rotatably disposed within conformable body 34, ascan be seen in FIGS. 2 and 4, and is rotatably coupled to a proximalhandle 38. Inner shaft 36 rotates about an axis 40, and has a probelumen 42 which is eccentric relative to axis 40. Hence, by rotatingproximal handle 38, the system user can selectively reposition probelumen 42 relative to positioning surface 32, and to the patient'stissues. This provides a simple mechanism to allow selectiveregistration of probe 24 with a target tissue of the tympanic membrane.In the exemplary embodiment, the engaging surfaces of inner shaft 36 androtatable body 34 define a rotational bearing 35 to accommodaterotational repositioning of inner shaft 36 relative to the conformablebody, thereby avoiding an injury to the engaged tissue surface when theprobe is moved. Optionally, a releasable rotational lock may inhibitinadvertent rotational movement of the inner shaft relative to theconformable body so as to avoid loss of registration. Alternatively,rotational friction of bearing 35 may be sufficient to maintainregistration, while still allowing manual movement of inner shaft 36 bymanual manipulation of handle 38. Axial displacement of rotatableconformable body 34 may be inhibited, optionally by engagement between asurface of the conformable body and a surface of one or more axialrestraining elements 37. Restraining elements 37 may be disposedproximally and/or distally of conformable body 34.

A variety of alternative articulatable mechanisms may be included toallow selective repositioning of probe lumen 42 relative to positioningsurface 32 in probe assembly 12. In some embodiments, one or moreselectively expandable structure (such as angioplasty-like balloons) maybe eccentrically disposed about a probe lumen tube within an outersheath, so that selective expansion of the eccentric structure(s)laterally repositions the probe lumen. More complex eccentric rotationmechanisms may vary the lateral offset of the lumen from shaft axis 40.For example, an intermediate eccentric shaft may be disposed between andselectively rotatable relative to eccentric inner shaft 36 and to anouter sheath. Alignment of the offset of the inner and intermediateeccentric shafts could move the probe lumen farther away from axis 40,while counteracting the eccentricity of inner shaft 36 with that of theintermediate shaft would move the probe lumen closer to axis 40. Stillfurther alternatives are possible, including axial sliding probe lumensupports which vary an eccentric angle of probe lumen 42 relative toaxis 40 adjacent distal end 30, steerable articulating probes which canbe selectively laterally offset from an axis of the probe lumen 42, andthe like.

In the exemplary embodiment, handle 38 of guide structure 22 comprises abody having a larger profile than shaft 26 for selective manual rotationof the inner shaft. Handle 38 (and probe assembly 12 in general) mayhave an appearance similar to a single earmuff when in use, or a pair ofprobe assemblies may be coupled together by a headband, giving theappearance of headphones or a helmet. Alternatively, a single probeassembly may be coupled to a headband. Optionally, a noise transmittermay be supported by guide structure 22 to transmit music, white noise,or the like, during treatment with the probe 24. This may help to maskthe mechanically transmitted sound perceived by a patient when tool 24pierces (or otherwise treats) a tympanic membrane, for example. Incombination with local anesthesia to inhibit pain, such a masking noisetransmitter might avoid alarming pediatric patients who are awake duringa tympanostomy tube placement procedure.

Referring to FIGS. 2 and 3, treatment probe 24 generally has a proximalactuation handle 44, a distal membrane piercing tip 46, and a probeshaft 48 therebetween. Probe 24 releasably carries a tympanostomy tube50 proximally of probe tip 46, the exemplary probe being used to bothform the myringotomy and to deploy the tympanostomy tube through thepierced membrane. Shaft 48 slides fittingly in probe lumen 42, so thatprobe 24 is oriented by the guide structure 22, and actuation of probehandle 44 by moving the probe handle toward the guide structure advancesthe probe tip 46 and tympanostomy tube 50. Engagement between a distalsurface 52 and of actuation handle 44 and a proximal surface 54 of guidestructure 22 limits the axial travel of the probe within the guidestructure to inhibit inadvertent injury of the tissue structures of themiddle or inner ear. Alternatively, a flange 55 of probe 24 adjacent tip46 may engage the surface of the tympanic membrane to limit distaltravel of the probe. Probe tip 46 and tympanostomy tube 50 mayoptionally be retractable into and/or through probe lumen 42 to helpavoid injury during insertion of shaft 26 into the external auditorycanal. Probe shaft 48 and surrounding guide structure shaft 26 may beflexible to accommodate bends of the auditory canal. The exemplary probewill have sufficient column strength adjacent tip 46 for penetrating thetympanic membrane. In the exemplary embodiment, treatment probe 24comprises solid cylindrical shaft.

Referring to FIG. 3, the eccentric location of probe lumen 42 withinouter shaft 36 can be clearly seen in this end view. An illuminationlight transmitter 58 is shown as a plurality of waveguides or fiberbundles, but may alternatively comprise a single waveguide or bundle. Animaging lens end 60 is also shown, as well as an aiming lighttransmitter 62. As described above, optical fibers or other transmissionmeans may transmit imaging light via probe assembly 12 for imaging thestructures of the ear. An aiming light beam may be transmitted fromaiming light transmitter 62, with the aiming beam acting as a lightpointer to indicate the alignment of the probe. Optionally, illuminationand aiming light may be generated locally at the probe assembly usinglight emitting diodes, laser diodes, or the like. The aiming beam andthe probe may be angled so that the aiming light beam forms a light spotat the portion of the tympanic membrane toward which the probe isaligned. This may be accomplished by angling the aiming beam and/orprobe lumen adjacent distal end 30. The distance between the guidestructure and the tympanic membrane may be determined by focus of theimaging system, by focus of the aiming beam, by intersection of aplurality of aiming beams, or the like. Alternatively, the aiming beamand probe may be aligned by inserting an aiming beam transmitter intothe probe lumen to verify orientation of the probe lumen, and thenreplacing the aiming beam transmitter with the probe. Aspiration and/orirrigation may be provided by one or more lumens 97 of the guidestructure 22 or of probe 24.

An exemplary probe tip 46 and tympanostomy tube 50 are illustrated inFIGS. 5A-6, while a tube deployed through a tympanic membrane TM isillustrated in FIG. 7. Probe tip 46 includes a distally oriented cuttingedge 62, which will often be surgically sharp. The associated tube hasan opening 64 with a first cross-sectional dimension 66 and a secondcross-sectional dimension 68 that is much smaller than the first, sothat the length of the cutting member is aligned with the elongateopening. Tube 50 has a proximal flange 72 and a distal flange 74 to helphold the tube in position through tympanic membrane TM, so that the tubeextends from an external auditory canal EAC to a middle ear ME. A distalsurface of distal flange 70 angles radially outwardly and proximally tofacilitate advancing the probe and tube through the tympanic membrane,the distal surface ofthe tube often being contiguous and/or conformalwith the distal surface of the probe tip. Optionally, there may be adistally oriented edge 76 on flange 70, this edge of the tube acting asan extension of the cutting blade edge to help push the distal flangethrough the membrane TM. The exemplary tympanostomy tube 50 comprises abiocompatible material such as stainless steel, silicone, PTFE, and thelike. Another probe system (and the method for its use) which may beused with the guide systems and methods of the present invention isdescribed in U.S. Pat. No. 5,026,378, entitled “Punch Myringotomy Systemand Method,” the full disclosure of which is incorporated herein byreference.

A variety of alternative tympanic tubes and deployment systems might beused with probe assembly 12 in system 10. For example, a tube withhelical thread 50 a and probe tip 46 a are illustrated in FIGS. 8A andB, and are more fully described in U.S. Pat. No. 5,775,336, the fulldisclosure of which is incorporated herein by reference. In thisembodiment a distal portion 80 of tool shaft 48 has a coiledconstruction to provide lateral flexibility with column strength. Stillfurther alternatives are possible, including a multi-part probe tip 46 bwhich releasably but positively restrains tube 50 in a channel 82, asillustrated in FIGS. 9A-9G. Sequentially sliding individual lateralportions of tip 46 b proximally, beginning with a central portion,allows the tip to be removed from within tube 50 without pulling thetube away from the tympanic membrane. Still further alternative tympanictube structures and deployment probes are possible, including many ofthose previously proposed or now in commercial use.

Referring now to FIG. 2A, aspiration, irrigation, and local drugdelivery proximal and/or distal of the tympanic membrane can beaccomplished using a lumen 51 in a probe 24 a. The lumen is containedwithin the treatment probe shaft 48 and has an exit port at the distalmembrane piercing tip 46.

Lumen 51 provides a passage for introduction of fluids such as salinefor irrigation, a local anesthetic agent to prepare the area for themyringotomy and tympanostomy procedure, and the like, as describedabove. Fluids may be delivered as a stream or as an atomized mist. Lumen51 can also be used to aspirate fluids from the external auditory canal,the middle ear, or the like.

Lumen 51 can be coupled to fluid delivery or vacuum aspiration sourcesby tubing 39. For example, tubing 39 may provide fluid communicationbetween lumen 51 and a source of irrigation fluid, typically a syringe43. Lumen 51 may similarly be coupled to a source of a drug, preferablyan anesthetic agent, typically a syringe 45. Lumen 51 may also beattached to a wall vacuum, a vacuum bottle, a vacuum pump unit 43, orany other vacuum source. This vacuum source may also employ a separatefluid collection chamber 47. The lumen can be attached to a plurality ofsuch components by separate tubing 39, or a single connection to thelumen can be used for a plurality of components using a manifold 49.

Referring now to FIG. 2B, aspiration, irrigation, local drug delivery,and the like may be provided via lumen 97 in guide structure 22. Thislumen may optionally provide passage for introduction of a manipulatabletube 39′. Preferably this tube will have a curved distal portion 41 tofacilitate aiming fluid toward a desired area of the external auditorycanal for irrigation, aspiration, drug delivery, and the like.

Tube 39′ can be coupled to a source of irrigation fluid, typically asyringe 43. It can be coupled to a source of a drug, preferably ananesthetic agent, typically a syringe 45. Tube 39′ can also be attachedto a wall vacuum, a vacuum bottle, a vacuum pump unit 43, or any othervacuum source. This vacuum source may also employ a separate fluidcollection chamber 47. A single tube 39′ can be used for a plurality offluid manipulation components via a manifold 49, or separate tubes canbe sequentially deployed through lumen 97.

Use of system 10 by a system operator O for treatment of a patient P canbe understood with reference to FIGS. 10-13E. Patient P will often be achild. Optionally, a mild sedative such as medazolam (Versed) may begiven to the patient at the discretion of the system operator, who mayoptionally be a doctor. A local anesthesia, such as Lidocaine drops, maybe placed in the ear (or ears) to be treated. Cerumen may be removedprior to and/or after mounting of the probe assembly. As mentionedabove, anesthesia, and other agents may alternatively be dispose on ordistributed through guide structure 22 of probe assembly 12. Water orother cerumenolytic agents such as Triethanolamine polypeptideoleatecondensate, hydrogen peroxide, or the like may also be introducedand/or removed via one or more lumen (see lumen 97 of FIG. 3) of theguide structure 22. Preferably, patient P is upright and awake with thesystem operator disposed in front of the patent, as illustrated in FIG.10. Operator O will direct the procedure videoscopically with referenceto an image 90 shown in viewing monitor 14, which may be placed behindand to the side of patient P.

A simplified model of ear E is shown in FIG. 12, and shows tympanicmembrane TM disposed within external auditory canal EAC. A target regionTR for deployment of tympanostomy tube 50 may be disposed below acentral portion of the membrane occupied by ossicles and other importantstructures (i.e., nerves and arteries) of the middle ear. As shown inFIG. 13A guide structure 22 is mounted to the ear E by inserting atleast a portion of shaft 26 into the external auditory canal EAC.Optionally, probe 24 may be separated from the guide structure duringinsertion of the shaft, and the inserted portion of the shaft maycomprise a deformable structure so as to avoid trauma during insertion.Once shaft 26 is in place, conformable body 32 engages the surroundingtissue surface so as to affix the guide structure.

This engagement may result from resilient expansion of a foam ofconformable body 32, for example. If probe 24 was not in place duringpositioning of the shaft it is inserted into probe lumen 42 as seen inFIG. 2.

With shaft 26 in place, operator O can then examine the tympanicmembrane TM image shown in monitor 14, as provided by the image capturedevice of probe assembly 12 (see imaging lens 60 in FIG. 3).Illumination for imaging of the tympanic membrane may be provided by oneor more illumination transmitting structure of the probe assembly 12(see illumination transmitting fibers 58 of FIG. 3).

As illustrated in FIGS. 13B and 11, a marker or pointer 94 may bedisplayed on image 90 as shown to the operator O. The pointer mayindicate an alignment of the probe 24 with the target region TR of thetympanic membrane TM, the pointer optionally being generated bytransmitting an imageable light beam from the probe assembly onto themembrane with an aiming beam transmitter 62, as described above withreference to FIG. 3. In some embodiments, a reticule or template may besuperimposed on the image displayed to the system operator, particularlywhere the alignment between the image capture device and the treatmentprobe is fixed. Such a reticule or template may comprise a simpletransparent overlay or acetate disposed over the surface of monitor 14.As shown in FIG. 11A, the image may alternatively be evaluated and anoverlaying image or template superimposed thereon to indicate a DangerZone (DZ), the anatomic region in which significant complication mayresult if the myringotomy with/without tube placement was performed.

Inner shaft 26 of guide structure 22 (see FIGS. 2 and 4) may be rotatedabout axis 40, as shown in FIG. 13C, to bring pointer 94 intoregistration with a target region TR oftympanic membrane TM. As can beunderstood with reference to FIGS. 10 and 4, this articulation of theguide structure may be accomplished by grasping and turning handle 38 soas to rotate the inner shaft 26 within positioning surface 32. If theimage capture device is affixed relative to the inner shaft, the imageof the tympanic membrane shown in monitor 14 may rotate during thisregistration process. Friction of the bearing between the positioningsurface and the probe lumen may be sufficient to maintain theorientation of the inner shaft when operator O is not manipulatinghandle 38. The lumen orientation may also be maintained by gentlepressure of the distal surface of the handle 38 or muff structureagainst the side of the patient's skull.

Once treatment probe 24 is properly registered with the target region TRof the tympanic membrane TM as illustrated in FIG. 13C, and once theregistration has been verified by determining that the location ofpointer 94 is within the target region, treatment is effected byactuating probe actuator 44. Actuator 44 may be advanced distally sothat probe tip 46 pierces tympanic membrane TM, as illustrated in FIG.13D. Inadvertent distal advancement of actuator 34 may be inhibited bydetent engagement between probe 24 and the guide structure 22, by areleasable locking mechanism, or the like. The actuation strokecontinues so that the distal flange of tympanostomy tube 50 is advancedthrough the tympanic membrane. The stroke may be terminated when aflange of the probe engages the tympanic membrane, when a limit surfaceof probe 24 engages a limit surface of the guide structure, or when thesystem operator visually determines appropriate by reference to monitor14. Optionally, an aspiration and/or irrigation lumen may have a port intip 46 of probe 24, so that the probe can be used to drain and/or clearmaterial from the middle ear while extending through tympanic membraneTM. Alternatively, separate fluid clearing and/or tube implantingstructures might be supported by guide structure 22.

As illustrated in FIG. 13E, treatment probe 24 can be withdrawnproximally from the tympanic membrane. The distal flange of tube 50should inhibit proximal motion of the tube, so that the tube slides offtip 46 of probe 24. The probe may optionally be withdrawn clear of guidestructure 22, as shown, and the imaging system may be used to verifythat tympanostomy tube 50 is properly placed.

While the exemplary structure and method have been described in somedetail, by way of example and for clarity of understanding, a variety ofchanges, adaptations, and modifications will be obvious to those ofskill in the art. Hence, the scope of the present invention is limitedsolely by the appended claims.

What is claimed is:
 1. A system for treating an ear of a patient havinga tympanic membrane and a tissue surface, the system comprising: a guidestructure having a proximal orientation and a distal orientation, theguide structure having a positioning surface; a tympanic membranetreatment probe oriented by the guide structure, the guide structuremaintaining registration of the treatment probe with a target region ofthe tympanic membrane when the positioning surface engages the tissuesurface of the ear.
 2. The system of claim 1, the tissue surfacecomprising an auditory canal, wherein the guide structure comprises aconformable body insertable into the auditory canal.
 3. The system ofclaim 2, wherein a shaft is rotatable within the conformable body aboutan axis, the treatment probe oriented eccentrically relative to the axisso that rotation of the shaft selectively registers the treatment probewith the target region.
 4. The system of claim 3, wherein the shaft islaterally flexible to conform with a bend of the auditory canal duringrotation of the shaft.
 5. The system of claim 4, wherein the treatmentprobe is laterally flexible to conform with a bend of the auditory canalduring rotation of the shaft.
 6. The system of claim 2, wherein theconformable body comprises a foam, further comprising an agent disposedon or in the foam, the agent comprising at least one member selectedfrom the group consisting of a local anesthetic agent, an antibacterialagent, an antibiotic agent, and a cerumenolytic agent.
 7. The system ofclaim 2, wherein the conformable body comprises at least one member ofthe group consisting of a balloon and a solid elastomer.
 8. The systemof claim 1, further comprising an image capture device supported by theguide structure for imaging the tympanic membrane, the image capturedevice coupled to a monitor.
 9. The system of claim 8, furthercomprising an illumination source carried by the guide structure forilluminating the tympanic membrane.
 10. The system of claim 1, furthercomprising a light transmitter directing a light beam distally, the beamaligned with the treatment probe to verifying registration of thetreatment probe with the target region.
 11. The system of claim 1,wherein the treatment probe comprises a probe shaft disposed in a lumenof the guide structure, the probe shaft coupled to an actuatoraccessible when the positioning surface engages the tissue surface, theprobe shaft advancing coaxially with the lumen in response to theactuator.
 12. The system of claim 11, wherein the treatment probe has adistal tip for piercing the tympanic membrane.
 13. The system of claim12, wherein the distal tip comprises a surgically sharp distal edge. 14.The system of claim 12, further comprising a tympanostomy tubereleasably carried on the probe shaft proximally of the tip.
 15. Thesystem of claim 14, wherein a distal surface of the distal tip iscontiguous with a distal surface of the tympanostomy tube.
 16. Thesystem of claim 14, wherein the tympanostomy tube comprises a proximalflange and a distal flange with a tubular body therebetween, the tubularbody having an elongate opening with a first cross-sectional dimensionand a second cross-sectional dimension greater than the first, the tipof the probe shaft having a distally oriented edge oriented along theheight, the distal surface of the distal flange of the tympanostomy tubeangling proximally and radially outwardly.
 17. The system of claim 11,wherein a limit surface of the treatment probe inhibits axial movementof the shaft after the probe pierces the tympanic membrane.
 18. Thesystem of claim 11, wherein the limit surface inhibits advancement of aproximal flange of the tympanostomy tube into a middle ear.
 19. Thesystem of claim 11, wherein the lumen is selectively repositionablerelative to the positioning surface for selective registration of thetreatment probe with the target region.
 20. The system of claim 1,further comprising a cerumen clearing lumen oriented distally from theguide structure.